Home » Trials » SLCTR/2013/027
The effects of an Ayurveda medicinal formulation, Swastha Thriphala ® on blood lipids in patients on atorvastatin for hyperlipidaemia
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SLCTR Registration Number
SLCTR/2013/027
Date of Registration
The date of last modification
May 02, 2019
Trial Status
Scientific Title of Trial
The effects of an Ayurveda medicinal formulation, Swastha Thriphala ® on blood lipids in patients on atorvastatin for hyperlipidaemia
Public Title of Trial
The effects of Swastha Thriphala®, an Ayurveda medicinal formulation on blood lipids
Disease or Health Condition(s) Studied
Hyperlipidaemia
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
ERC/13-018 (Ethics Review Committee of the Sri Lanka Medical Association)
What is the research question being addressed?
Does Swastha Thriphala ® taken as an adjunct to atorvastatin have a beneficial effect on patients with hyperlipidaemia?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
Participants will be randomized into two arms.
The intervention arm will receive Swastha Thriphala ®, 1-4 tablets (dose to be decided by the patient) to be taken daily at bedtime for 12 weeks. The control arm will receive a placebo, 1-4 tablets (dose to be decided by the patient) to be taken at bedtime for 12 weeks.
Atorvastatin will be continued for both arms at prescribed doses
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Change in blood lipids: total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides. |
[ At recruitment, 6 weeks and 12 weeks of treatment ] |
Secondary outcome(s)
|
1.
Improvement in quality of life variables (sleep, appetite, daily activities of living, bowel movements, fatigue, mental worry, concerns about future, family life), |
[ At recruitment, 6 weeks and 12 weeks of treatment ] |
Target number/sample size
200 participants
Countries of recruitment
Sri Lanka
Anticipated start date
2013-09-15
Anticipated end date
2014-09-10
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
Link Natural Products (Pvt) Ltd
Regulatory approvals
Status
Approved
Date of Approval
2013-07-05
Approval number
ERC/13-018
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Sri Lanka Medical Association, |
| Institutional Address: | No 6, Wijerama Mawatha, Colombo 00700 Sri Lanka |
| Telephone: | +94-11-2693324 |
| Email: | erc.slma@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Professor. C de FW Goonaratna
Registrar, Ceylon Medical College Council
Faculty of Medicine, Colombo 8
+9411-4612643
si7np5e@gmail.com
Contact Person for Public Queries
Professor. C de FW Goonaratna
Registrar, Ceylon Medical College Council
Faculty of Medicine, Colombo 8
+9411-4612643
si7np5e@gmail.com
Primary study sponsor/organization
Link Natural Products (Pvt) Ltd
#199, Kew Road,
Colombo 02
Sri Lanka
(+94 11) 2409294/ 2441300
(+94 11) 2409293
rd@linknaturalproducts.com
www.linknaturalproducts.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
